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FDA Oversight of Mobile Health Field Found Controversial

By Vera Gruessner

- The mobile health field has been blossoming tremendously, as new applications, wearable devices, remote monitoring tools, and digital technologies continue to hit the market and gain popularity across the consumer base. Today, smartphones and tablets can actually benefit diagnosis, population health management, and consumer health and wellness.

Mobile Health Field

Additionally, devices within the mobile health field can actually collect more patient data than ever before, which may impact population health tracking by public health agencies as well as offer more analysis for physicians looking to improve the quality of their medical care services.

However, a paper published by the New England Journal of Medicine explains that the Food and Drug Administration (FDA) has found regulating the mobile health field rather challenging and complex. This could be a significant issue, as the FDA is responsible for ensuring mHealth devices are safe and secure for patient use.

Both Congress and professionals working in the mobile health field have found some of the oversight conducted by the FDA with regard to mHealth apps controversial. Many are concerned that regulations could put an end to the innovations taking place within the market as well as its burgeoning growth.

Nonetheless, this type of oversight is “increasingly important.” With the wide range of mHealth apps and wearable devices out on the market, both doctors and patients are finding it difficult to measure their quality or effectiveness. It is vital for healthcare professionals as well as typical, everyday consumers to understand both the risks and benefits of mHealth products.

In February of 2015, the FDA issued a guidance on mobile medical applications in order to “inform manufacturers, distributors, and other entities about how the FDA intends to apply its regulatory authorities to select software applications intended for use on mobile platforms.”

The FDA stated that the agency will only be using its regulatory powers to maintain oversight of mobile health devices and mobile apps “whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended.” Essentially, patient safety is at the forefront of FDA regulations when it comes to the mobile health field.

The FDA strongly encourages designers and developers working in the mobile health field to follow Good Manufacturing Practices both when creating their products and also upgrading any applications.

“The variety and availability of smartphone applications—or apps—have exploded in recent years as multi-tasking consumers increasingly use their phones to keep up with the latest on news, finance, and health. Apple says its iPhone App Store has more than 350,000 apps, and Android, BlackBerry, Windows, and other smartphones account for tens of thousands more. With so many apps on the market, it’s no wonder the number of health care related apps has also spiraled,” the FDA reported in an article. “The Food and Drug Administration is now proposing guidelines that outline the small number of mobile apps the agency plans to oversee—medical apps that could present a risk to patients if the apps don’t work as intended.”


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